Nurix Therapeutics Announces U.S. FDA Lifts Partial Clinical Hold on NX-2127 Phase 1 Trial
11 Marzo 2024 - 5:00AM
Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical stage
biopharmaceutical company developing targeted protein modulation
drugs designed to treat patients with cancer and inflammatory
diseases, today announced that the U.S. Food and Drug
Administration (FDA) has lifted the partial clinical hold on the
U.S. Phase 1a/1b study evaluating NX-2127 in adults with
relapsed/refractory B-cell malignancies. The partial clinical hold
on the study was announced by Nurix on November 1, 2023, following
the company’s communication to the FDA of its intention to
transition to an improved manufacturing process.
“We are pleased with the timely resolution of the partial
clinical hold, which allows us to reinitiate enrollment in the
NX-2127 Phase 1 study utilizing drug product from our new
manufacturing process,” said Paula G. O’Connor, M.D., executive
vice president and head of clinical development at Nurix.
“Following our clinical data disclosures at the American Society of
Hematology Annual Meeting last year and the recent scientific
publication in the journal Science, we are seeing an acceleration
of interest in our BTK degrader programs.”
Nurix plans to reinitiate enrollment with the new chirally
controlled drug substance in a standard dose escalation study
within the current Phase 1a/1b trial. Nurix plans to prioritize
enrollment of patients with aggressive forms of non-Hodgkin’s
lymphoma (NHL) including diffuse large B-cell lymphoma (DLBCL) and
mantle cell lymphoma (MCL) where durable complete responses have
previously been observed. Patients currently enrolled in the
clinical study who are deriving clinical benefit from NX-2127
manufactured with the prior process may continue to receive that
treatment in accordance with the study protocol.
About NX-2127
NX-2127 is a novel bifunctional, orally bioavailable,
investigational new drug that degrades Bruton’s tyrosine kinase
(BTK) and cereblon neosubstrates Ikaros (IKZF1) and Aiolos (IKZF3).
NX-2127 is currently being evaluated in a Phase 1 clinical trial in
patients with relapsed or refractory B cell malignancies.
Additional information on the ongoing clinical trial can be
accessed at www.clinicaltrials.gov (NCT04830137).
About Nurix Therapeutics, Inc.
Nurix Therapeutics is a clinical stage biopharmaceutical company
focused on the discovery, development and commercialization of
innovative small molecules and antibody therapies based on the
modulation of cellular protein levels as a novel treatment approach
for cancer, inflammatory conditions, and other challenging
diseases. Leveraging extensive expertise in E3 ligases together
with proprietary DNA-encoded libraries, Nurix has built DELigase,
an integrated discovery platform, to identify and advance novel
drug candidates targeting E3 ligases, a broad class of enzymes that
can modulate proteins within the cell. Nurix’s drug discovery
approach is to either harness or inhibit the natural function of E3
ligases within the ubiquitin-proteasome system to selectively
decrease or increase cellular protein levels. Nurix’s wholly owned,
clinical stage pipeline includes targeted protein degraders of
Bruton’s tyrosine kinase, a B-cell signaling protein, and
inhibitors of Casitas B-lineage lymphoma proto-oncogene B, an E3
ligase that regulates activation of multiple immune cell types
including T cell and NK cells. Nurix is headquartered in San
Francisco, California. For additional information visit
http://www.nurixtx.com.
Forward-Looking Statements
This press release contains statements that relate to future
events and expectations and as such constitute forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. When or if used in this press release, the
words “anticipate,” “believe,” “could,” “estimate,” “expect,”
“intend,” “may,” “outlook,” “plan,” “predict,” “should,” “will,”
and similar expressions and their variants, as they relate to
Nurix, may identify forward-looking statements. All statements that
reflect Nurix’s expectations, assumptions or projections about the
future, other than statements of historical fact, are
forward-looking statements, including, without limitation,
statements regarding: Nurix’s plans and expectations with respect
to the Phase 1a/1b study evaluating NX-2127, including plans to
reinitiate enrollment utilizing drug product from the new
manufacturing process and plans to prioritize enrollment in certain
indications, including DLBCL and MCL; the therapeutic potential of
Nurix’s drug candidates, including NX-2127; the extent to which
NX-2127 or Nurix’s other drug candidates may address a range of
diseases; and the potential advantages of Nurix’s scientific
approach and DELigase™ platform. Forward-looking statements reflect
Nurix’s current beliefs, expectations, and assumptions. Although
Nurix believes the expectations and assumptions reflected in such
forward-looking statements are reasonable, Nurix can give no
assurance that they will prove to be correct. Forward-looking
statements are not guarantees of future performance and are subject
to risks, uncertainties and changes in circumstances that are
difficult to predict, which could cause Nurix’s actual activities
and results to differ materially from those expressed in any
forward-looking statement. Such risks and uncertainties include,
but are not limited to: (i) whether Nurix will be able to advance,
obtain regulatory approval of and ultimately commercialize its drug
candidates, including NX-2127; (ii) the unexpected emergence of
adverse events or other undesirable side effects during clinical
development; (ii) uncertainties related to the timing and results
of clinical trials; (iv) whether Nurix will be able to fund
development activities and achieve development goals; (v) the
impact of economic and market conditions and global and regional
events on Nurix’s business, clinical trials, financial condition,
liquidity and results of operations; (vi) whether Nurix will be
able to protect intellectual property and (vii) other risks and
uncertainties described under the heading “Risk Factors” in Nurix’s
Annual Report on Form 10-K for the fiscal year ended November 30,
2023, and other SEC filings. Accordingly, readers are cautioned not
to place undue reliance on these forward-looking statements. The
statements in this press release speak only as of the date of this
press release, even if subsequently made available by Nurix on its
website or otherwise. Nurix disclaims any intention or obligation
to update publicly any forward-looking statements, whether in
response to new information, future events, or otherwise, except as
required by applicable law.
Contacts:
InvestorsJason Kantor, Ph.D.Nurix
Therapeuticsir@nurixtx.com
Elizabeth Wolffe, Ph.D.Wheelhouse Life Science
Advisorslwolffe@wheelhouselsa.com
MediaAljanae ReynoldsWheelhouse Life Science
Advisorsareynolds@wheelhouselsa.com
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